Status:
WITHDRAWN
AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.
Lead Sponsor:
Dr. Sabrina Overhagen
Conditions:
Iliac Artery Disease
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
This PMCF study is designed as prospective, multi-center study to collect real-life data. The rationale of this study is to confirm and support the clinical safety and performance of the aforemention...
Eligibility Criteria
Inclusion
- \- Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
- Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study (depending on the used device during the procedure) Patient is \>18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient is eligible for treatment with
- the Lokum L-Quest guidewire
- and/or the Lokum Amplatz guidewire
- and/or the Slider Hydrophilic Nitinol Guidewire
- and/or the AltoSa-XL PTA balloon
- and/or the AltoSa-XL Gemini balloon catheter
- and/or the Optimus-XL CoCr Bare Metal Stent
- and/or the Optimus-XL CVS PTFE Covered Stent, as described in the IFU for each device.
Exclusion
- Application in coronary, cerebral arteries and central circulatory system
- Known contraindication to peripheral arterial and visceral vasculature treatment - Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
- Known contraindication and/or allergy to (a component of) an investigational device
- Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding
- Life expectancy of less than twelve months
- Any planned surgical intervention/procedure within 30 days of the study procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Patient is currently participating in another investigational drug or device study that has not completed the entire follow-up period.
- Device-related exclusion criteria (not applicable for guidewire):
- Known contraindications given in the IFU of Optimus CoCr and Optimus-CVS PTFE- Covered Balloon-Expandable Stent which includes treatment of renal arteries, aneurysms adjacent to site of stent implantation and neurovascular treatment
- Known contraindications given in the IFU of AltoSa-XL-PTA and AltoSa-XL-Gemini Balloon catheter:
- patients with a contraindication for anti-platelet/anti-coagulant therapy
- patients with excessive vessel tortuosity
- dilatation of in-stent restenosis and highly calcified stenosis
- patients with perforated vessels evidenced by extravasation of contrast media
- patients with a known hypersensitivity to nylon
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04822727
Start Date
May 1 2021
End Date
December 31 2023
Last Update
August 23 2023
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